Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized trastuzumab in combination with capecitabine or 5-fluorouracil and cisplatin for the treatment of adult patients with HER2 positive metastatic adenocracinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. The production information for trastuzumab in this indication further specifies that trastuzumab should only be used in patients with metastatic gastric cancer whose tumors have HER2 overexpressed as defined by IHC 2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result, as measured by an accurate and validated assay.
This is written in the approval document as:
Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Citation
Roche Registration GmbH. Herceptin (trastuzumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf. Revised March 2023. Accessed March 12, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | HER2-positive | Esophagogastric Adenocarcinoma | Capecitabine, Cisplatin, Trastuzumab | |
| Sensitivity (+) | HER2-positive | Esophagogastric Adenocarcinoma | Cisplatin, Fluorouracil, Trastuzumab | |
| Sensitivity (+) | ERBB2 amplification | Esophagogastric Adenocarcinoma | Capecitabine, Cisplatin, Trastuzumab | |
| Sensitivity (+) | ERBB2 amplification | Esophagogastric Adenocarcinoma | Cisplatin, Fluorouracil, Trastuzumab |